T-SHARP: Tele-Harm Reduction

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05208697

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

240

Enrollment

Locations

Arms

30.9

Anticipated Duration (Months)

120

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.

Condition or Disease	Intervention/Treatment	Phase
IV Drug Usage HIV Infections Hepatitis C	Behavioral: Tele-Harm Reduction Other: off-site linkage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tele-Harm Reduction for Rapid Initiation of Antiretrovirals in People Who Inject Drugs: a Randomized Controlled Trial

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tele-Harm Reduction (THR) THR utilizes 2 components. Component 1: telehealth technology facilitated by a peer harm reduction counselor to connect the participant with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program (ADAP). Component 2: utilizes the syringe services program (SSP)-based peer harm reduction counselor to work with participants in identifying individual-specific barriers and facilitators to medication adherence.	Behavioral: Tele-Harm Reduction THR is telehealth-enhanced, on-demand services including low-barrier access to antiretrovirals, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an SSP, integrated with the provision of evidence-based naloxone and injection equipment.
Active Comparator: off-site linkage to HIV care introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic	Other: off-site linkage standard of care linkage to a Ryan White clinic

Arm

Intervention/Treatment

Experimental: Tele-Harm Reduction (THR)

THR utilizes 2 components. Component 1: telehealth technology facilitated by a peer harm reduction counselor to connect the participant with medical case managers and enroll patients in Ryan White/AIDS Drug Assistance Program (ADAP). Component 2: utilizes the syringe services program (SSP)-based peer harm reduction counselor to work with participants in identifying individual-specific barriers and facilitators to medication adherence.

Behavioral: Tele-Harm Reduction

THR is telehealth-enhanced, on-demand services including low-barrier access to antiretrovirals, medications for substance use disorder and hepatitis C treatment. It includes mobile phlebotomy, harm reduction counseling, medication management, telehealth mental health/substance use disorder services-- all delivered via an SSP, integrated with the provision of evidence-based naloxone and injection equipment.

Active Comparator: off-site linkage to HIV care

introduces the participant to an SSP HIV/HCV linkage specialist and discusses linkage to a traditional Ryan White clinic

Other: off-site linkage

standard of care linkage to a Ryan White clinic

Outcome Measures

Primary Outcome Measures

Viral suppression [up to 12 months]
HIV viral load <200 copies/ml time-averaged

Secondary Outcome Measures

Initiation of medications for opioid use disorder [up to 12 months]
Positive urine drug screen for buprenorphine, naltrexone or methadone at study follow-up visit after MOUD is prescribed.
HCV cure [up to 12 months]
HCV treatment initiated resulting in negative HCV RNA at 12 weeks post treatment completion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age 18 or older
able to speak English
enrolled in IDEA Miami or IDEA Tampa SSPs
injection drug use in past 12 months by self-report
willing and able to sign informed consent, provide locator information and medical records release
testing reactive for HIV by rapid test
HIV RNA>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date)

Exclusion Criteria:

testing HIV negative via rapid test
receipt of THR intervention in the past 6 months
inability to provide informed consent
planning to leave the area within 12 months
Principal or site investigator discretion
currently in prison or jail
Enrollment in Clinical Trials Network 121

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136
2	University of South Florida	Tampa	Florida	United States	33612

Sponsors and Collaborators

University of Miami
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Hansel Tookes, MD, MPH, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hansel Tookes, Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT05208697

Other Study ID Numbers:

20201516
DP2DA053720

First Posted:

Jan 26, 2022

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hansel Tookes, Associate Professor, University of Miami

heroin

needle exchange

syringe services program

Additional relevant MeSH terms:

Hepatitis C

Study Results

No Results Posted as of Aug 10, 2022